PROJECT DESCRIPTION

Invest between 350 000 - 9 000 000 EUR for Orphan Drug Discovery and Development faster through innovative most unprecedented speed, accuracy, diversity in silico methods and using the power of cutting-edge artificial intelligence (AI) for 22 new small molecule drugs of rare and ultra rare diseases by the end of 2022

STEP 1

Choose your investment plan and rare disease

STEP 2

Setup new biotechnology Company in Bulgaria (part of EU) with % ownership

STEP 3

Start Orphan Drug Discovery and Development (Phase Drug Discovery and Development + Pre-Clinical Studies) (Disease Indication; Target ID; Assay development; Hi Identification; Hit-to-Lead; In-vivo POC/Lead; Lead Optimization; Pre-Clinical) - 12 months

STEP 4

Registration Orphan Drug Designation applications in parallel by using the ‘common application’ for submissions to the European Medicines Agency (EMA) The FDA Office of Orphan Products Development (OOPD) and the US FDA Office of Orphan Products Development (OOPD) - 6 months

STEP 5

Registration of Orphan new drug candidates Intellectual Property (IP) - Patent through WIPO.INT - 18 months

STEP 6

Exit strategies: Next rounds Venture Capital (for Clinical phase I, II, III, Registration and Market) // M&A (Mergers and acquisitions) // Licensing deal // IPO (Initial Public Offer) - 12 months

Licensing, through a classical royalties-based agreement, the set of information and eventually the intellectual property, to a “profit” third party, will be a pharmaceutical or a biotech company.

In case an interested third party will not be identified, e.g. due to a very low prevalence of the specific disease, an alternative pathway consisting of a full development financed entirely by non profit money will be actively explored.

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We're aiming 22 new treatments of rare and ultra rare diseases by 2022

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Orphan Drugs

These are medicines which are developed specifically for rare diseases.

Orphan Drugs are medicines for rare diseases which, under normal circumstances, would not be developed by pharmaceutical companies because they would be unable to recoup their costs. We provide orphan Drug Discovery and Development faster through innovative most unprecedented speed, accuracy, diversity in silico methods and using the power of cutting-edge artificial intelligence (AI) and this change dramatically time and cost of Orphan Drug Discovery and Development process. Globally a range of incentives have been implemented to encourage companies to develop orphan medicines.

EUROPE

Companies that are looking to gain "orphan medicinal product designation" for their products in Europe must submit their application to the Committee for Orphan Medicinal Products (COMP). They need to demonstrate that they intend to develop their product(s) "for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect not more than 5 in 10,000 persons in the European Union" (this equates to about 185,000 cases) (Ref: EMA/COMP).

To benefit from the incentives offered companies have to submit an application to the EMA to request "orphan designation" for their medicine. Once the medicine is awarded "orphan drug" status, the company can then take full advantage of the incentives on offer.

These incentives include:

Protocol assistance (scientific advice during the product development phase)
Marketing authorisation (10 year marketing exclusivity)
Financial incentives (fee reductions or exemptions)
Country-specific incentives detailed in an inventory made available by the European Commission

We together can apply for our medicine to have "orphan drug" status. We can then take advantage of the incentives listed above and maximise our return on investment.

At the same time, we will be improving the quality of life of those patients who suffer rare diseases.

We considering both the American and European markets for ours Orphan Drugs, we recommends that the Orphan Drug Designation applications should run in parallel. This can be achieved by using the ‘common application’ for submissions to the European Medicines Agency (EMA) and the US FDA. This reduces overall timescales and therefore, minimises financial risk and investment.

USA

The FDA Office of Orphan Products Development (OOPD) is responsible for the evaluation of scientific and clinical data submissions from sponsors seeking Orphan Drug Designation for their product.

In the US an 'Orphan Drug' is a drug or biologic: “intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.”

As of 13 December 2016, Section 3052 of the 21st Century Cures Act (Pub. L. No. 114-255) changed the population estimate to qualify for Humanitarian Use Device (HUD) designation. The HUD designation is now defined as “a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year”. Previously the requirement stated that designation was for “fewer than 4,000”.

GLOBAL

Under normal circumstances the Pharmaceutical Industry doesn't develop medicines or devices for such small numbers of patients. There are a range of worldwide incentives, however, to encourage the life science industry to develop Orphan Drugs. Many companies are now taking advantage of these incentives.

We provide orphan Drug Discovery and Development faster through innovative most unprecedented speed, accuracy, diversity in silico methods and using the power of cutting-edge artificial intelligence (AI) and this change dramatically time and cost of Orphan Drug Discovery and Development process.

Become Adopter